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ARTICLE TITLE: American Cancer Society Colorectal Cancer Survivorship Care Guidelines
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Nicole L. Erb, BA, reports cooperative agreement funding from the American Cancer Society/Centers for Disease Control and Prevention (ACS/CDC) for the National Cancer Survivorship Resource Center project. Anne Willis, MA, reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project as well as a grant from Genentech and event sponsorships from Amgen Oncology, Takeda Oncology, and Genentech outside the submitted work. Jennifer K. Bretsch, MS, reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Research Center project. Mandi L. Pratt-Chapman, MA, reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project as well as a grant from Genentech; a consulting fee from Pfizer; and event sponsorships from Amgen Oncology, Genentech, and Takeda Oncology outside the submitted work. Rachel S. Cannady, BS, reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project. Sandra L. Wong, MD, MS reports grants from the American Cancer Society (Research Scholar Grant RSG-12-269-01-CPHPS) and the Agency for Healthcare Research and Quality (K08HS020937-01) outside the submitted work. Johnie Rose, MD,PhD, reports grants from Genomic Health, Inc, outside the submitted work. Rebecca L. Cowens-Alvarado, MPH, reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project. April L. Barbour, MD, MPH, FACP, Durado D. Brooks, MD, MPH, Khaled El-Shami, MD PhD, Kevin C. Oeffinger, MD, Katherine B. Sharpe, MTS CPH, and Kevin D. Stein, PhD, have no financial relationships or interests to disclose.
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American Cancer Society Colorectal Cancer
Survivorship Care Guidelines
Khaled El-Shami, MD, PhD1; Kevin C. Oeffinger, MD2; Nicole L. Erb, BA3*; Anne Willis, MA4; Jennifer K. Bretsch, MS, CPHQ5; Mandi L. Pratt-Chapman, MA6; Rachel S. Cannady, BS7; Sandra L. Wong, MD, MS8; Johnie Rose, MD, PhD9; April L. Barbour, MD, MPH, FACP10; Kevin D. Stein, PhD11; Katherine B. Sharpe, MTS12; Durado D. Brooks, MD, MPH13;
Rebecca L. Cowens-Alvarado, MPH14
Colorectal cancer (CRC) is the third most common cancer and third leading cause of cancer death in both men and women and second lead-ing cause of cancer death when men and women are combined in the United States (US). Almost two-thirds of CRC survivors are livlead-ing 5 years after diagnosis. Considering the recent decline in both incidence and mortality, the prevalence of CRC survivors is likely to increase dra-matically over the coming decades with the increase in rates of CRC screening, further advances in early detection and treatment and the aging and growth of the US population. Survivors are at risk for a CRC recurrence, a new primary CRC, other cancers, as well as both short-term and long-short-term adverse effects of the CRC and the modalities used to treat it. CRC survivors may also have psychological, reproductive, genetic, social, and employment concerns after treatment. Communication and coordination of care between the treating oncologist and the primary care clinician is critical to effectively and efficiently manage the long-term care of CRC survivors. The guidelines in this article are intended to assist primary care clinicians in delivering risk-based health care for CRC survivors who have completed active therapy. CA Cancer J Clin 2015;000:000–000.VC2015 American Cancer Society.
Keywords: colorectal cancer, survivorship, clinical care, follow-up, guidelines, primary care, quality of life, survivorship care plan, long-term effects, late effects, care coordination
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1Assistant Professor of Medicine, The George Washington University, School of Medicine and Health Sciences, Washington, DC;2Director, Cancer Survivorship Center, Memorial Sloan Kettering Cancer Center, New York, NY;3Program Manager, National Cancer Survivorship Resource Center, American Cancer Society, Atlanta, GA;4Director, Patient-Cen-tered Programs, The George Washington University Cancer Institute, Washington, DC;5Director, Performance Improvement, American Society of Clinical Oncology, Alexandria, VA; 6Director, The George Washington University Cancer Institute, Washington, DC;7Behavioral Scientist, Behavioral Research Center/National Cancer Survivorship Resource Center, American Cancer Society, Atlanta, GA;8Associate Professor of Surgery, Department of Surgery, University of Michigan, Ann Arbor, MI;9Assistant Professor, Department of Family Medicine and Community Health, Case Western Reserve University School of Medicine/Case Comprehensive Cancer Center, Cleveland, OH;10Associate Professor of Medicine, The George Washington University School of Medicine and Health Sciences, Washington, DC;11Vice President, Behavioral Research, Director, Behavioral Research Center, American Cancer Society, Atlanta, GA;12Senior Vice President, Patient and Caregiver Support, American Cancer Society, Atlanta, GA;13Director, Cancer Control Intervention, American Cancer Society, Atlanta, GA;14Vice President, Behavioral Research, South Atlantic Health Systems, American Cancer Society, Atlanta, GA
Corresponding author:Nicole L. Erb, BA, Program Manager, National Cancer Survivorship Resource Center, American Cancer Society, 250 Williams Street, NW, Suite 600, Atlanta, GA 30303; [email protected]
DISCLOSURES:This journal article was supported in part by Cooperative Agreement #5U55DP003054 from the Centers for Disease Control and Prevention. Its con-tents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention. No industry fund-ing was used to support this work. Nicole L. Erb reports cooperative agreement fundfund-ing from the American Cancer Society/Centers for Disease Control and Prevention (ACS/CDC) for the National Cancer Survivorship Resource Center project. Anne Willis reports cooperative agreement funding from the ACS/CDC for the National Can-cer Survivorship Resource Center project as well as a grant from Genentech and event sponsorships from Amgen Oncology, Takeda Oncology, and Genentech outside the submitted work. Jennifer K. Bretsch reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Research Center project. Mandi L. Pratt-Chapman reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project as well as a grant from Genentech; a consulting fee from Pfizer; and event sponsorships from Amgen Oncology, Genentech, and Takeda Oncology outside the submitted work. Rachel S. Cannady reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project. Sandra L. Wong reports grants from the American Cancer Society (Research Scholar Grant RSG-12-269-01-CPHPS) and the Agency for Healthcare Research and Quality (K08HS020937-01) outside the submitted work. Johnie Rose reports grants from Genomic Health, Inc, outside the submitted work. Rebecca L. Cowens-Alvarado reports cooperative agreement funding from the ACS/CDC for the National Cancer Survivorship Resource Center project. The remaining authors have no financial disclosures to declare.
In addition to the authors of the current article, the American Cancer Society thanks the following members of the Colorectal Cancer Survivorship Care Guidelines Expert Work-group for their contribution to the development of the Colorectal Cancer Survivorship Care Guidelines: Corry Chapman, MD (Family Medicine Physician, Catholic Charities, Wash-ington, DC); Zana Correa, NP, BC (Nurse Practitioner, Colorectal Survivorship Clinic, Memorial Sloan Kettering Cancer Center, New York, NY); Sarah Huff, RN, BSN, OCN (Colorectal Cancer Patient Navigator, David Lee Cancer Center, Charleston Area Medical Center, Charleston, WV); Paul J. Limburg, MD, MPH (Professor of Medicine, Gastroen-terology and Hepatology, Preventive, Occupational and Aerospace Medicine, Mayo Clinic, Rochester, MN); Jeffrey A. Meyerhardt, MD, MPH (Clinical Director, Gastrointestinal Cancer Center, Senior Physician, Dana-Farber Cancer Institute; Associate Professor, Department of Medicine, Harvard Medical School, Boston, MA); Fran Zandstra, RN, MBA, OCN (Former Executive Director, Office of Cancer Survivorship (retired), The University of Texas MD Anderson Cancer Center, Houston, TX); and Robert A. Smith, PhD (Vice Pres-ident, Cancer Screening, American Cancer Society, Atlanta, GA). The American Cancer Society Colorectal Cancer Survivorship Care Guidelines Expert Workgroup thanks the fol-lowing individuals for their helpful review and comments on this article: Catherine M. Alfano, PhD (Vice President, Survivorship, American Cancer Society, Atlanta, GA); Otis Brawley, MD, FACP (Chief Medical Officer, American Cancer Society, Atlanta, GA); Lewis E. Foxhall, MD (Vice President, Health Policy, Ofc of the EVP, Cancer Network, The Uni-versity of Texas MD Anderson Cancer Center, Houston, TX); Ted Gansler, MD, MPH, MBA (Director, Medical Content, American Cancer Society, Atlanta, GA); Michael Jefford, MD, PhD, MPH (Deputy Head, Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia); Thomas K. Oliver (Director, Guidelines, Quality and Guidelines, American Society of Clinical Oncology, Alexandria, VA); Steven R. Patierno, PhD (Deputy Director, Duke Cancer Institute; Professor of Medicine; Professor of Pharma-cology and Cancer Biology; and Professor in Community and Family Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC); Marcus Plescia, MD, MPH (Public Health Director, Mecklenburg County Health Department; Adjunct Professor PH Leadership Program, UNC Gillings School of Public Health, Charlotte, NC); and Rich-ard Wender, MD (Chief Cancer Control Officer, American Cancer Society, Atlanta, GA).
Introduction
Over the past 2 decades, increasing attention has been given to understanding the long-term and late effects expe-rienced by cancer survivors as a result of their cancer diag-nosis or treatment.1-4 Long-term (side) effects caused by cancer or its treatment that are present during treatment and may persist for months or years may be physical or psy-chosocial in nature. In contrast, late effects of the cancer or cancer therapy may occur months or even years after a cancer diagnosis and again may include second cancers, physical problems, or psychosocial issues. Along the cancer continuum, there are at least 3 distinct phases of cancer sur-vivorship: from diagnosis to the end of initial treatment, the transition from treatment to extended survival, and long-term survival.5While clinical practice guidelines exist for diagnosis and treatment, there are few evidence-based clinical care guidelines for posttreatment care. The ever increasing number of cancer survivors living after treatment poses a challenge to oncology and primary care clinicians to provide ongoing optimal clinical follow-up care.6To meet this demand, it is important to equip primary care clinicians with the necessary resources to recognize and manage the health risks and maximize quality of life (QoL) of cancer survivors. The National Comprehensive Cancer NetworkVR
(NCCNVR
) has developed consensus-based guidelines for the treatment of patients with colon and rectal cancers, which also include some recommendations regarding follow-up care after completion of treatment.7,8 In addi-tion, the NCCN has developed survivorship care guidelines addressing long-term or late occurring psychosocial and physical problems and preventive health.9In addition, the American Society of Clinical Oncology (ASCO) clinical practice guidelines for cancer survivorship care focus on prevention and management of symptoms experienced by survivors of many types of cancer. To date, ASCO has released 3 evidence-based cancer survivor care guidelines focused on fatigue, anxiety and depression, and neuropa-thy.10-12ASCO has also updated their fertility preservation guideline13and offers a provisional clinical opinion on the integration of palliative care into oncology care.14
The American Cancer Society (ACS) CRC Survivorship Care Guidelines build on previous guidelines by providing primary care clinicians with recommendations for providing comprehensive care for CRC survivors. These guidelines provide guidance on: 1) methods to identify and manage the potential physical and psychosocial long-term and late effects of CRC and its treatment, 2) surveillance for recur-rence and screening for second primary cancers, 3) health promotion, and 4) how to enhance communication between the oncology team and primary care clinicians. The goal of these guidelines is to optimize the care delivered for cancer survivors and to help improve the overall health and QoL of CRC survivors.
Gaps in posttreatment cancer survivorship resources and clinical follow-up care were identified through the work of the National Cancer Survivorship Resource Center, a col-laboration between the American Cancer Society and The George Washington University Cancer Institute, funded by a 5-year cooperative agreement from the Centers for Disease Control and Prevention. (The Survivorship Center; cancer.org/survivorshipcenter).15 Aims of The Survivorship Center are to help survivors achieve optimal health and QoL and to increase awareness of posttreatment survivorship as a public health issue. To this end, The Survivorship Center convened a group of experts to review existing literature and clinical practices to develop comprehensive clinical follow-up care guidelines for CRC survivors, specifically those who are stage I-III, with no evidence of disease.
Background
Approximately 132,700 individuals will be diagnosed with CRC in the US in 2015.16 The incidence of CRC has declined over the past 20 years, in large part because of increased screening and removal of precancerous polyps. The rate of decline in incidence is greater among non-Hispanic white males than among African American males and is similar between non-Hispanic white and African American females.16 Other racial and ethnic groups have lower inci-dence rates than these 2 populations.17 Approximately 49,700 patients will die from CRC in 2015.16Mortality rates are highest among African American males and are approxi-mately 50% higher than rates in the second highest group, non-Hispanic white males, followed by American Indian/ Alaska Native males. Among females, mortality rates are sig-nificantly higher for African Americans, followed by Ameri-can Indians/Alaska Natives, and non-Hispanic whites17 (Fig. 1: Colorectal Cancer Incidence and Mortality Rates* by Race/Ethnicity and Sex, United States, 2006-2010).18
As of January 1, 2014, it is estimated that CRC survivors comprise more than 1.2 million (about 9%) of the nearly 15 million cancer survivors alive in the US, making CRC the sec-ond and third most common cancer site among male and female cancer survivors, respectively.19The majority of CRC survivors are aged 60 years or older.16The overall health and QoL experienced by survivors is influenced in part by the stage at diagnosis and the types and duration of therapy. Only 40% of CRC is diagnosed at a local stage (stages I and II), whereas 36% of cancers are diagnosed at a regional stage, involving the regional lymph nodes (stage III), and 20% are diagnosed at a distant stage, when distant metastases have occurred (stage IV).17The type of treatment will vary, depending on the stage at diagnosis, but the most common treatment is surgery, with additional therapy including systemic chemotherapy and radi-ation therapy (the latter is used much more often in rectal can-cer than in colon cancan-cer) given either in the neoadjuvant or
adjuvant setting. Potential physical long-term and late effects affecting CRC survivors include chronic peripheral neuropa-thy, infertility, secondary cancers, and bowel dysfunction. Survivors may also experience psychosocial issues, such as distress, depression, anxiety, body image, sexual dysfunction and intimacy concerns, as well as financial issues resulting from workforce displacement and/or costs of treatment.20
Methods
Literature Review
To develop the ACS CRC Survivorship Care Guidelines, The Survivorship Center staff conducted an initial review of relevant literature and reviewed publically available US and international clinical practice guidelines. The original litera-ture search was conducted in the fall of 2011 using PubMed, identifying articles published between 2000 and 2011 using combinations of the following keywords and phrases: cancer survivor, colon cancer, rectal cancer, colorectal cancer, chem-otherapy, cognitive dysfunction, depression, distress manage-ment, fecal incontinence, follow-up care, genetic counseling and testing, guidance, guidelines, hand and foot syndrome, health promotion, late effects, late sequelae, long-term effects, meta-analysis, monitoring, neuropathy, pain man-agement, palliative care, posttreatment, primary care physi-cian, psychosocial, radiation, recurrence, screening, second cancer, sexual dysfunction, surgery, surveillance, survivor, survivorship, symptom management, systematic review, and treatment complications. Studies were excluded that
1) reported on studies of childhood cancer, 2) reported on qualitative studies, 3) were published in languages other than English, and 4) specifically addressed metastatic (stage IV) CRC (due to the likelihood that these survivors participate in ongoing treatment and do not fall into the “long-term/ extended survivorship” phases).
In January and February 2012, the initial literature search was supplemented by an environmental scan of publically available US and international clinical practice guidelines and reports relevant to the clinical management of CRC patients and survivors, regardless of intended readership. Surveillance guidelines specific to CRC from the NCCN and national and international sources relevant to the impact of CRC and interventions for long-term and late effects were reviewed. Sources included the: ACS, American College of Gastroen-terology, American Gastroenterological Association, Ameri-can Psychosocial Oncology Society, ASCO, AmeriAmeri-can Society of Colon and Rectal Surgeons, American Society for Gastrointestinal Endoscopy, American Society for Radiation Oncology, Canadian Association of Psychosocial Oncology, Institute of Medicine (IOM), National Cancer Institute, NCCN, National Guidelines Clearinghouse, MD Anderson Clinical Tools and Resources Colon and Rectal Cancer Sur-vivorship algorithm, Oncology Nursing Society, Society of American Gastrointestinal and Endoscopic Surgeons, Soci-ety of Gastroenterology Nurses and Associates, Inc., and Society of Surgical Oncology.
From May 2012 through June 2014, the CRC guideline was put on hold as The Survivorship Center directed its
FIGURE 1.Colorectal Cancer Incidence and Mortality Rates by Race/Ethnicity and Sex: United States, 2006-2010. NHW indicates non-Hispanic white; NHB, non-Hispanic black; API, Asian/Pacific Islander; AI/AN, American Indian/Alaska Native. Reprinted from: Siegel R, Desantis C, Jemal A. Colorectal cancer statistics, 2014. CA Cancer J Clin. 2014;64:104-117; and Surveillance, Epidemiology, and End Results (SEER) Program. SEER*Stat Database: Mortality-All COD, Aggregated With State, Total US (1969-2010) (Katrina/Rita Population Adjustment); Bethesda, MD: National Cancer Institute, Division of Cancer Control and Population Sciences, Surveillance Research Program, Cancer Statistics Branch; 2013, released April 2013, reprinted with permis-sion from the National Cancer Institute. Underlying mortality data were provided by the National Center for Health Statistics, 2013.
efforts to writing the ACS Prostate Cancer Survivorship Care Guidelines manuscript. Prostate cancer is the first cancer type to be published in a series of new ACS survi-vorship care guidelines developed and funded in part through The Survivorship Center cooperative agreement.21 In September 2014, The Survivorship Center reconvened the ACS CRC Survivorship Care Guidelines Expert Workgroup to update the literature review, review the lev-els of evidence according to previously published methods, and consider any revisions. A small writing group was con-vened to complete the guidelines manuscript.
Due to the time lapse, in September 2014, an updated literature search was conducted. Search terms included can-cer survivor1review or meta-analysis or systematic review 1 guidelines or guidance paired with colorectal cancer; colorectal cancer survivor or colorectal cancer patient post-treatment 1 (symptom management, late effects, long-term effects, psychosocial care, palliative care, health pro-motion, surveillance, screening for new cancers, self-management, guidelines or guidance, follow up or follow-up, side effects 1 chemotherapy, side effects 1 radiation, side effects 1 surgery, treatment complications, genetic counseling and testing, survivor or patient interventions, provider interventions, provider education, and barriers). Literature identified included: guidelines/guidance devel-oped by other organizations (eg, NCCN follow-up recom-mendations, ASCO follow-up recommendations), specific medical centers (eg, The University of Texas MD Ander-son Cancer Center), or other countries (eg, the Australian Cancer Survivorship Centre); recent meta-analyses and review articles (since 2004 after publication of the National Action Plan for Cancer Survivorship); and individual stud-ies. The highest priority was given to articles that met the following criteria: peer-reviewed publication in English since 2004, unless a seminal article published before that date still carried the most weight, including randomized controlled trials (RCTs), prospective studies, and well-conducted, population-based, case-control studies; large studies of more than 200 cancer cases analyzed; and with high-quality assessment of covariates and analytic methods; and analyses controlled for important confounders (eg, pre-existing comorbid conditions).
In total, 226 articles (Literature Review Summary Table; see online supporting information) met the inclusion criteria for the literature review and were used to develop the guidelines.
Literature Synthesis and Workgroup Recommendations
In May 2012, The Survivorship Center staff integrated evi-dence from the initial literature review to develop an initial draft of the ACS CRC Survivorship Care Guidelines that was reviewed by the expert workgroup. The Survivorship Center
Steering Committee and staff and the ACS medical and can-cer control leadership nominated experts who were caring for CRC survivors in either primary care or surgical/oncologic set-tings. Workgroup members were selected based on their expertise in at least one of the following domains: gastroenter-ology, health services, medical oncgastroenter-ology, oncology nursing, preventive medicine, primary care, public health, and surgical oncology. The expert workgroup consisted of 9 initial mem-bers who were e-mailed a structured 13-question survey about the accuracy and relevance of the draft guidelines document (Appendix A; see online supporting information). Written responses were compiled and distributed in advance of a con-ference call to discuss the feedback and reach consensus on conflicting recommendations.
Led by Khaled El-Shami, MD, PhD, of The GW Med-ical Faculty Associates, a Hematologist/Oncologist with board certification in Medical Oncology and Internal Med-icine, the expert workgroup participated in a webinar dis-cussion of the existing evidence base as well as themes and discrepancies from the comments. Based on written and verbal feedback, The Survivorship Center staff revised the draft guidelines. The Survivorship Center staff sought additional evidence and clinical expertise to support practice-based recommendations and to explore issues identified by the expert workgroup members that were not identified by the literature review. Based on a combination of published evidence and practice-based experience, The Survivorship Center staff drafted clinical follow-up care recommendations to be considered for inclusion in the guidelines. This revised draft of guidelines recommenda-tions was presented to the American Cancer Society Mission Outcomes Committee, Chief Medical Officer, and National Board of Directors for review and was approved in May 2012.
In September 2014, the initial literature review was updated using the search terms outlined in the literature review section.21Expert workgroup members were asked to consider the following criteria as they synthesized their findings from the published literature:
1. Level of evidence (defined as level I, meta-analyses of RCTs; level IA, RCT of CRC survivors; level IB, RCT based on cancer survivors across multiple sites; level IC, RCT based not on cancer survivors but on the general population experiencing a specific long-term or late effect [eg, managing urinary incontinence, erectile dysfunction, etc]; level IIA, non-RCT based on CRC survivors; level IIB, non-RCT based on cancer survivors across multiple sites; level IIC, non-RCT based not on cancer survivors but on the general popu-lation experiencing a specific long-term or late effect; level III, case study; and level 0, expert opinion, obser-vation, clinical practice, literature review, or pilot study);
2. Consistency across studies, including across study designs (separating results by study design when presenting the evidence);
3. Dose-response when presenting long-term or late effects associated with chemotherapy or radiation therapy; 4. Race/ethnicity differences in diagnosis and treatment that
may impact the risk of long-term or late effects; and 5. Second primary cancers for which CRC survivors are at
high risk due to cancer treatment exposure, genetic fac-tors, lifestyle behaviors, etc.
Although new articles were added to the literature review, there was no change in the guidelines. In May 2015, the guide-lines manuscript was sent to internal and external experts for final review and comment before submission for publication. The process of cancer survivorship care guidelines development was aligned with the ACS process for creating cancer screening guidelines, and a comparison of this methodology has been previously published.21 In December 2011,22 changes were effected to ensure the ACS cancer screening guidelines devel-opment process was in alignment with the new IOM standards for how guidelines should be developed.23To align with the ACS cancer screening guidelines process, every 5 years these survivorship care guidelines will be updated as new research is available to support revision.
Guidelines for the Primary Care Management
of CRC Survivors
Each of the essential components of comprehensive cancer survivorship care are discussed in the following sections: Surveillance for CRC Recurrence and Screening for Second Primary Cancers, Assessment and Management of Physical and Psychosocial Effects of CRC and Treatment, Routine Health Promotion Needs, and Coordination of Care Among Specialists and Primary Care Clinicians.1
Surveillance for CRC Recurrence
Surveillance for CRC recurrence is applicable to survivors who have completed primary treatment for stage I, II, and III cancer and are without evidence of disease (Table 1: Sur-veillance Guidelines for Colorectal Cancer Recurrence and Screening and Early Detection of Second Primary Cancers [Stage I-III]). The goal of surveillance is to detect recurrent or metachronous (eg, new primary) disease early, thereby improving long-term outcomes through timely intervention.
Although these guidelines can be extrapolated to surveil-lance strategies for patients with resected, metastatic (stage IV) CRC without evidence of disease, there are little to no data to inform these recommendations.
The ASCO clinical practice guideline endorsement of the Cancer Care Ontario Guidelines on Follow-Up Care, Sur-veillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer emphasized that if a patient
is not a candidate for surgery or systemic therapy because of severe comorbid conditions, then surveillance tests should not be performed.24 Testing should only be performed in patients for whom the results will change treatment deci-sions. We endorse this ASCO recommendation.
Recommendation 1: Clinical follow-up care provided to CRC survivors should be individualized based on the specific diagnosis and treatment protocol. Level of evidence 52A
The guiding principle of surveillance is that it should be based on assessment of a patient’s risk of recurrence in the context of functional status and patient preferences. Factors associated with a high risk of recurrence include poorly dif-ferentiated histology (exclusive of cancers with microsatel-lite instability-high [MSI-H]); lymphatic or vascular invasion; bowel obstruction; having had fewer than 12 lymph nodes examined; perineural invasion; localized per-foration; and close, indeterminate, or positive resection margins.
In addition, unless there is a family history or a known genetic syndrome, CRC survivors are at average risk for other cancers, and it is recommended that primary care clinicians screen for second primary cancers as they would in the general population.7,8
Recommendation 2: CRC survivors should receive surveillance colonoscopy according to a schedule based on risk. Level of evidence5 2A
The survivorship timeline (time zero) starts at the time of resection or at the time of diagnosis if resection is not part of index treatment (see Table 1). Testing intervals are based on the assumption that treatment is not ongoing and that no evidence of recurrence or metastatic disease was found at the end of treatment. The literature is not definitive with regard to how often surveillance for recurrent disease should be conducted and, to a lesser extent, which modalities to use for surveillance. In the US, there are surveillance guidelines from the NCCN and ASCO. These recommendations dif-fer slightly because of difdif-ferences in results from included clinical trials25 used to form guideline recommendations. Results from trials do not give a consistent answer to ques-tions about an optimal surveillance program and, impor-tantly, do not provide definitive evidence on outcomes related to early detection of recurrent disease or second primary tumors.
For survivors of colon and rectal cancers, the NCCN recom-mends the following surveillance schedule, which we endorse (see Table 1).7For survivors of all stages of CRC, colonoscopy is recommended 1 year after resection unless no preoperative colonoscopy occurred due to emergent presentation, in which case, colonoscopy is recommended 3 to 6 months after surgery. If no abnormalities or advanced adenomas are found, then repeat colonoscopy is recommended at 3 years and every 5 years thereafter.
Generally, ASCO agrees with the NCCN recommenda-tions but does not recommend the colonoscopy at 3 years. Rather, ASCO recommends colonoscopy every 5 years after the initial post-therapy colonoscopy. Detection of adenoma-tous polyps during surveillance will necessitate more fre-quent follow-up.
Recommendation 3: CRC survivors should receive a history and physical every 3 to 6 months in the first 2 years, and every 6 months in years 3 through 5. Level of evidence 52A
For survivors of stage II and III cancers, for the first 2 years, physicians should take the patient’s history and
conduct a physical examination as an opportunity to identify symptoms, offer counseling, and coordinate post-treatment care.
Recommendation 4: Carcinoembryonic antigen testing should be conducted every 3 to 6 months for the first 2 years if a patient is a potential candidate for further intervention and every 6 months for years 3 through 5 if a patient is a potential candidate for further intervention; carcinoembryonic antigen testing is not recommended after 5 years. Level of evidence52A
For the first 2 years, carcinoembryonic antigen (CEA) testing is recommended every 3 to 6 months. Over the next
TABLE 1. Surveillance Guidelines for Colorectal Cancer Recurrence and Screening and Early Detection of Second Primary Cancers (Stage I-IIIa)
GUIDELINE: LEVEL OF EVIDENCE AND CONSENSUS52Ab
1-2 Years posttreatmentb
lH & P every 3-6 mo
lCEA every 3-6 mo if patient is a potential candidate for further intervention
lChest/abdominal/pelvic CT every 12 mo (stages I-II if at high risk for recurrence and stage III)
lColonoscopy in year 1; if advanced adenoma, repeat in 1 year; if not, repeat in 3 years
3-5 Years posttreatmentb
lH & P every 6 mo
lCEA every 6 mo if patient is a potential candidate for further intervention
lChest/abdominal/pelvic CT every 12 mo (stages I-II if at high risk for recurrence and stage III)
lColonoscopy in year 4; if no advanced adenoma, repeat every 5 y
5 Years posttreatmentb
lCEA not recommended
lChest/abdominal/pelvic CT not recommended
lColonoscopy every 5 y starting 9 y after resection if no advanced adenoma
lProctoscopy (rectal cancer only) not recommended
NOT recommended
lRoutine blood tests (eg, CBC, liver function test)
lAfter 5 y, routine CEA monitoring
lAfter 5 y, routine CT scans
lRoutine use of PET/CT at any stage
lPET scans are not considered an acceptable substitution for CT scans
Optimal timing unknown
lScreen survivors for breast, cervical, and prostate cancers as average risk according to American Cancer Society guidelines
lCounsel and treat patients with known or suspected HNPCC or FAP according to high-risk screening guidelines
CBC indicates complete blood count; CEA, carcinoembryonic antigen; CT, computed tomography; FAP, familial adenomatous polyposis; H & P, history and physical; HNPCC, hereditary nonpolyposis colorectal cancer; PET, positron emission tomography.aThe only surveillance recommendation for stage I colon can-cer is colonoscopy. bThe National Comprehensive Cancer Network rating indicates uniform NCCN consensus that the intervention is appropriate based on lower-level evidence. Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN GuidelinesVR
) for Colon Cancer V.2.2015 and Rectal Cancer Version 2.2015.VC 2015 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN GuidelinesVR
and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORKVR
, NCCNVR
, NCCN GUIDELINESVR
, and all other NCCN content are trademarks owned by the National Comprehensive Cancer Network, Inc.
3 years, CEA testing is recommended every 6 months when the potential exists for further therapeutic interven-tion of recurrent disease. After 5 years, routine CEA is not monitored.
Recommendation 5: Chest/abdominal/pelvic computed tomography should be performed every 12 months (stages I-II if at high risk for recurrence and stage III) for up to 5 years; routine positron emission tomography-computed tomography is not recommended at any stage and routine computed tomography is not recommended after 5 years. Level of evidence5 2A
In addition the NCCN recommends, for stage III cancer and those at high risk for recurrence, annual chest/abdo-men/pelvis computed tomography (CT) scans are recom-mended annually for up to 5 years. After 5 years, routine CT scans are not recommended. Routine use of positron emission tomography (PET)/CT is not recommended in this setting.7
In contrast to the NCCN recommendations, ASCO rec-ommends CT scans of the abdomen and chest annually for only 3 years for CRC survivors. For rectal cancer survivors, a pelvic CT scan is also recommended, and the oncologist’s judgment should be used to determine the frequency of pel-vic scans based on recurrence risk in patients (typically every 6-12 months for 2 or 3 years, then annually until 3-5 years after surgery). PET scans are not recommended as an acceptable substitution.
ASCO has endorsed the Cancer Care Ontario Clinical Practice Guideline on surveillance protocols24 for patients with stage II and III CRC. In the guideline, shorter inter-vals of follow-up are recommended for patients at higher risk of recurrence (eg, stage IIIC, genetic syndromes, and CEA fluctuations). A medical history, physical examina-tion, and CEA testing should be performed every 3 to 6 months for 5 years. A shorter interval is considered earlier in the surveillance period, because 80% of recurrences occur in the first 2.0 to 2.5 years in patients with a high risk of recurrence. The ASCO panel noted the principles of condi-tional survival estimates, which are based on time already survived after diagnosis and treatment. Taking survival time into account allows for improved accuracy of prognos-tication. For CRC, there are very high conditional survival rates at 4 to 5 years after treatment, lending evidence to support “stop dates” for surveillance protocols, especially because disease-specific survival is very good after 3 years without clinical, serologic, or radiologic evidence of disease recurrence.26
In contrast to the NCCN recommendations, ASCO rec-ommends CT scans of the abdomen and chest annually for only 3 years for CRC survivors. For rectal cancer survivors, a pelvic CT scan is also recommended, and the oncologist’s judgment should be used to determine the frequency of pel-vic scans based on recurrence risk in patients (typically every
6-12 months for 2 or 3 years then annually until 3-5 years after surgery). PET scans are not considered an acceptable substitution.
Screening for Second Primary Cancers
Recommendation 6: CRC survivors should receive age-appropriate and gender-age-appropriate screening for patients with an average risk, except for female CRC survivors with Lynch syndrome (see Recommendation 7). Level of evidence52A
Screening for other malignancies, such as breast, cervical, prostate, or lung cancer, should be continued for CRC sur-vivors according to age, gender, and risk factor criteria as per ACS guidelines.27 Table 2 summarizes the ACS screening recommendations for each of these cancers among average-risk individuals.27 In addition, some CRC survivors have an elevated risk of second primary cancers because of genetic factors and, thus, should undergo a more intensive regimen of screening.
Patients should not undergo cancer screening without first having a discussion with their primary care clini-cian about the risks, benefits, and limitations of the particular screening modalities and the implications of positive screening tests. This is as true for cancer survi-vors as it is for the general population. In considering the benefits of screening, primary care clinicians and patients should consider the patient’s overall health and life expectancy and whether any patient characteristics place the patient at elevated risk for a specific cancer type.
When possible, primary care clinicians should take the opportunity to acknowledge to patients when professional society recommendations disagree. Such discordance is most notable in the cases of breast and prostate cancer screening recommendations. Although the ACS currently recommends annual mammography beginning at age 40 years,28updated guidelines are expected to be released later this year. The US Preventive Services Task Force (USPSTF) provides a far more conservative recommenda-tion of beginning biennial mammography at age 50 years and does not support teaching breast self-examination at the time of this writing. Given an average age of CRC diagnosis of 68 years,17 it is likely that mammographic screening will be indicated for a substantial portion of female survivors regardless of the guideline followed. For males, the USPSTF recommends against routine prostate cancer screening. The ACS suggests that patients and their primary care clinicians make the decision regarding whether to screen based on an adequate understanding of the harms (overdiagnosis, overtreatment, false-positive tests, complications of testing and treatment), benefits (decreased likelihood of late-stage diagnosis of prostate cancer), and uncertainties of screening.29
TABLE 2. American Cancer Society Recommendations for the Early Detection of Breast, Cervix, Colorectal, Endometrial, and Prostate Cancer in Average Risk Asymptomatic Adults and Lung Cancer in High Risk Asymptomatic Adults
CANCER SITE POPULATION TEST OR PROCEDURE FREQUENCY
Breast Women
ages20 y
Breast self-examination (BSE) It is acceptable for women to choose not to do BSE or to do BSE regularly
(monthly) or irregularly; beginning in their early 20s, women should be told about the benefits and limitations of BSE; whether or not a woman ever performs BSE, the importance of prompt reporting of any new breast symptoms to a health pro-fessional should be emphasized; women who choose to do BSE should receive instruction and have their technique reviewed on the occasion of a periodic health examination
Clinical breast examination (CBE) For women in their 20s and 30s, it is recommended that CBEs be part of a periodic
health examination, preferably at least every 3 years; asymptomatic women aged
40 y should continue to receive a CBE as part of a periodic health examination,
pref-erably annually
Mammography Begin annual mammography at age 40 ya
Cervix Women, ages
21-65 y
Pap test and HPV DNA test Cervical cancer screening should begin at age 21 y; for women ages 21-29 y,
screening should be done every 3 y with conventional or liquid-based Pap tests; for women ages 30-65 y, screening should be done every 5 y with both the HPV test and the Pap test (preferred) or every 3 y with the Pap test alone (acceptable);
women aged>65 y who have had3 consecutive negative Pap tests or2
con-secutive negative HPV and Pap tests within the last 10 y, with the most recent test occurring in the last 5 y, and women who have had a total hysterectomy (for a benign condition) should stop cervical cancer screening; women at any age should not be screened annually by any screening method
Colorectal Men and
women,
ages50 y
Guaiac-based fecal occult blood test (gFOBT) with at least 50% test sensitivity for cancer, or fecal immunochemical test (FIT) with at least 50% test sensitivity for cancer, or
Annual starting at age 50 y; testing at home with adherence to manufacturer’s recom-mendation for collection techniques and number of samples is recommended; FOBT with the single stool sample collected on the clinician’s fingertip during a digital rectal examination in the health care setting is not recommended; guaiac-based toilet bowl FOBT tests also are not recommended; compared with guaiac-based tests for the detection of occult blood, immunochemical tests are more patient-friendly and are likely to have equal or better sensitivity and specificity; there is no justification for repeating FOBT in response to an initial positive finding
Stool DNA test, or Every 3 y, starting at age 50 y
Flexible sigmoidoscopy (FSIG), or Every 5 y, starting at age 50 y; FSIG can be performed alone, or consideration can
be given to combining FSIG performed every 5 y with a highly sensitive gFOBT or FIT performed annually
Double-contrast barium enema, or Every 5 y, starting at age 50 y
Colonoscopy, or Every 10 y, starting at age 50 y
CT colonography Every 5 y, starting at age 50 y
Endometrial Women, at
menopause
At the time of menopause, women at average risk should be informed about risks and symptoms of endometrial cancer and strongly encouraged to report any unex-pected bleeding or spotting to their physicians
Lung Current or former
smokers (quit within past 15 y) ages 55-74 y in good health with at least a 30 pack-year history
Low-dose helical CT (LDCT) Clinicians with access to high-volume, high-quality lung cancer screening and
treat-ment centers should initiate a discussion about annual lung cancer screening with apparently healthy patients ages 55-74 y who have at least a 30 pack-year smok-ing history and who currently smoke or have quit within the past 15 y; a process of informed and shared decision making with a clinician related to the potential benefits, limitations, and harms associated with screening for lung cancer with LDCT should occur before any decision is made to initiate annual lung cancer screening; smoking-cessation counseling remains a high priority for clinical attention in discussions with current smokers, who should be informed of their continuing risk of lung cancer; screening should not be viewed as an alternative to smoking cessation
Prostate Men, ages
50 y
Digital rectal examination and prostate-specific antigen test
Men who have at least a 10-y life expectancy should have an opportunity to make an informed decision with their health care provider about whether to be screened for prostate cancer after receiving information about the potential benefits, risks, and uncertainties associated with prostate cancer screening; prostate cancer screening should not occur without an informed decision-making process
CT, computed tomography; gFOBT, guaiac fecal blood occult blood test; Pap, Papanicolaou.aBeginning at age 40 years, annual CBE ideally should be per-formed before mammography.
Recommendation 7: Female CRC survivors with Lynch syndrome should receive annual endometrial sampling and transvaginal ultrasound. Level of evidence 52A
Women with Lynch syndrome, also known as hereditary nonpolyposis colorectal cancer (HNPCC), constitute a group with a clearly elevated risk for subsequent cancer diagnoses. These women have a 27% to 71% lifetime risk of endometrial cancer—greater than that of CRC—and a 3% to 14% lifetime risk of ovarian cancer.30,31Therefore, based on expert opinion, the ACS suggests that women who are confirmed carriers of a Lynch syndrome mutation or who are likely carriers based on mutation status or incidence pat-terns of family members begin screening with annual endo-metrial biopsy at age 35 years.27
Regardless of HNPCC or CRC status, endometrial sam-pling has a sensitivity of 99.6% in postmenopausal women and 91% in premenopausal women for the detection of endometrial carcinoma32and is minimally invasive. Trans-vaginal ultrasound (TVUS) alone is not a reliable screen for endometrial cancer in premenopausal women given highly variable endometrial thickness during the menstrual cycle. The sensitivity of TVUS in asymptomatic postmenopausal women is approximately 83%,33which is considerably lower than that of biopsy in this group, although it is also thought to be useful for the detection of ovarian neoplasms. Evi-dence does support the effectiveness of prophylactic hyster-ectomy and oophorhyster-ectomy as a means of prevention for both endometrial and ovarian cancer in women with HNPCC.34 The decision as to whether to pursue this option should be made after careful discussion with the patient of the risks of surgery and future fertility plans. Finally, endometrial biopsy should be performed in any woman with Lynch syndrome who reports irregular or postmenopausal vaginal bleeding.35
Assessment and Management of Physical and
Psychosocial Long-Term and Late Effects of
CRC and its Treatment
The risk of physical long-term and late effects after ther-apy for CRC is associated with several factors, including: 1) type of primary tumor, 2) type of chemotherapy, 3) duration and dose of treatment(s) (increasing cumula-tive dose and duration of therapy increases the potential risk), and 4) age of patient during treatment (Table 3: Guidelines for the Assessment and Management of Phys-ical and Psychosocial Long-Term and Late Effects). Commonly used chemotherapy and biotherapy agents used to treat CRC include 5-fluorouracil (5-FU), oxali-platin, and capecitabine. These drugs have been adminis-tered to patients in different combinations and at various dosages and lengths of time, which may relate to the pos-sible long-term and late effects. Primary care clinicians
should refer to the patient’s cancer treatment summary for the specific drugs and doses. Table 4 lists potential physical and psychosocial long-term and late effects asso-ciated with surgery, radiation, and chemotherapy, which are described in the rest of this section (Table 4: Sum-mary of Potential Long-Term and Late Effects of Colo-rectal Cancer and Its Treatment).
Bowel/Gastrointestinal Issues
Recommendation 8: (a) Ask CRC survivors about whether they are experiencing diarrhea, rectal bleeding, rectal incontinence, or other bowel dysfunction and (b) treat symptoms similar to those in the general
population. Level of evidence 5III
Chronic diarrhea, ie, diarrhea lasting longer than 4 weeks that limits activities and negatively impacts QoL, is one of the most common long-term conditions, affecting almost half of CRC survivors.36Among patients who undergo low anterior resection (LAR) for rectal cancer and other lower surgical anastomoses, bowel dysfunction is common, includ-ing increased stool frequency, bowel incontinence, and perianal irritation; decreased stool and flatus discrimination; and more incomplete evacuations.37,38Rates of bowel prob-lems are significantly increased in rectal cancer survivors treated with pelvic radiation, regardless of whether it was administered preoperatively or postoperatively.39,40
Empirical support to guide the optimal management of bowel problems is limited (level III evidence). However, antidiarrheal medications, such as loperamide (Imodium) or diphenoxylate/atropine (Lomotil), are common first-line treatment for chronic diarrhea after radiation therapy. Dietary adjustments, especially the elimination of raw vegetables, can be of benefit.41 Low-fat diets, probiotic supplementation, and elemental diets also may be beneficial among patients treated with pelvic radiation.42 Persistent symptoms may necessitate referral to gastroen-terology. Options for the treatment of fecal incontinence include medical therapy, such as bulking agents or anti-diarrheal medications to reduce stool frequency and improve stool consistency, biofeedback therapy to improve control of the pelvic floor and abdominal wall muscula-ture, and surgery.
Cardiovascular Effects
Recommendation 9: Monitor CRC survivors who are obese or who have had prior coronary artery disease and received 5-fluorouracil or capecitabine for cardiovascular disease. Level of evidence5 0
The risk of cardiovascular morbidity does not appear to be increased in long-term CRC survivors. In a large British cohort study, Khan and colleagues did not observe an excess risk of heart failure or coronary artery disease among CRC survivors.43 Nevertheless, there are
TABLE 3. Guidelines for the Assessment and Management of Physical and Psychosocial Long-Term and Late Effects
GUIDELINE LEVEL OF EVIDENCEa
Bowel/gastrointestinal issues III
lDiscuss frequency and/or urgency of bowel movements or loose bowels
lAssess for rectal ulceration and/or bleeding
lAssess for rectal emptying problems/incontinence
lDiscuss bowel function and symptoms (eg, rectal bleeding) with survivors
lRefer survivors with persistent rectal symptoms (eg, bleeding, sphincter dysfunction, rectal urgency and
frequency) to the appropriate specialist
Cognitive function 0
lScreen for problems such as depression and anxiety that might worsen cognition and refer for treatment
lRefer patients with a positive screen for formal neurocognitive training
Dental/oral 0
lMonitor for loss of taste and dry mouth
lRecommend saliva substitutes or medications to provide symptom relief
lRecommend attention to good oral hygiene (flossing, brushing with fluoride toothpaste, regular dental
care)
Distress/depression/anxiety 1/0 (psychosocial screen), IIA
(stoma)
lLevel of risk: Higher for those with a stoma and those with sexual dysfunction
lScreen for distress/depression/anxiety periodically (at least annually) using a simple screening tool, such as
the Distress Thermometer
lManage distress/depression using in-office counseling resources, pharmacotherapy, or prescribe exercise as
appropriate
lIf office-based counseling and treatment are insufficient, refer survivors experiencing distress/depression for
further evaluation and or treatment by appropriate specialists
Fatigue I
lAssess with a validated instrument such as the MDASI, BFI, FACT-G7, or FACT-C
lRecommend psychosocial support interventions and/or mind-body interventions
lRecommend 150 minutes of physical activity per week plus strength training per ACSNutrition &
Physical Activity Guidelines for Cancer Survivors
lRecommend optimizing nutrition per ACSNutrition & Physical Activity Guidelines for Cancer
Survivors
lFor chronic fatigue, refer to rehabilitation
Neuropathy 0
lFocus on prevention; strong evidence for therapy is lacking
lAssess with Total Neuropathy Score or other validated tool for patients receiving oxaliplatin
lHigher risk criteria
Patients who receive a cumulative dose of>900 mg/m2are at higher risk
Patients with preexisting neuropathy, alcoholism, and diabetes mellitus
lTreat with duloxetine (moderate recommendation)
lNo evidence to support tricyclic antidepressants, gabapentin, or topical gel containing baclofen,
amitripty-line HCl, or ketamine; but these therapies have been used for other neuropathic pain conditions
lRefer to rehabilitation and pain management as needed
Ostomy/stoma I
TABLE 3.Continued
GUIDELINE LEVEL OF EVIDENCEa
lMonitor and manage sexual dysfunction as needed
lMonitor and refer for psychosocial support for increased distress, depression and anxiety, and poorer
qual-ity of life
Pain I
lAssess for incisional hernia with complications
lConsider opioid analgesics, use of pain- management services, if available; incorporation of behavioral
interventions/physical activity and/or rehabilitation/physical therapy have demonstrated efficacy for pain control in systematic reviews in other cancers or pain syndromes
Sexual function/fertility 0, IA (oral phosphodiesterase-5
inhibitors in men), IC (vaginal moisturizers and lubricants for women)
lLevel of risk: Affects a small percentage of CRC survivors
lHigher risk criterion: Women who receive pelvic radiotherapy
lDiscuss urogenital dysfunction/sexual dysfunction (eg, erectile dysfunction, dyspareunia, vaginal dryness,
incontinence)
lMen who receive pelvic radiotherapy or oxaliplatin may be at higher risk for gonadotoxicity (limited
evidence)
Evaluate for Leydig cell dysfunction
Initiate testosterone replacement as indicated
lWomen survivors of rectal cancer with a stoma are at higher risk for vaginal dryness and dyspareunia
Recommend vaginal moisturizers and water or silicone-based lubricants during intercourse
lFor men with erectile dysfunction, treat with oral phosphodiesterase-5 inhibitors
lSexual dysfunction is correlated with greater psychosocial distress—see recommendation 12 for management
recommendations
Urinary/bladder issues IC
Surgery
lAssess for stress, urge, and overflow urinary incontinence in patients who underwent surgery
lRecommend Kegel exercises for stress incontinence unless denervation occurred during surgery
lRecommend anticholinergic drugs for stress incontinence
lRecommend antimuscarinic drugs for urge or mixed incontinence
lPatients with hypocontractile bladders may require catherization
lRefer patients with prolonged urinary retention postoperatively to urologist
Radiation
lAssess for incontinence, frequency, urgency, dysuria, or hematuria in patients who underwent surgery
lRecommend limiting caffeine and fluid intake and avoiding foods that irritate the bladder, such as citrus
and tomatoes, for irritative symptoms
lRefer patients with persistent hematuria to a urologist for cystoscopy to investigate secondary causes
ACS indicates American Cancer Society; BFI, Brief Fatigue Inventory; CRC, colorectal cancer; FACT-C, Functional Assessment of Cancer Therapy-Colorectal Cancer; FACT G7, 7-item Functional Assessment of Cancer Therapy-General (for patients with any tumor type); MDASI, MD Anderson Symptom Inventory. a
Levels of evidence include: I, meta analyses of randomized controlled trials (RCTs); IA, RCT of colorectal cancer survivors; IB, RCT based on cancer survivors across multiple sites; IC, RCT based not on cancer survivors but on the general population experiencing a specific long-term or late effect (eg, chronic diar-rhea, sexual dysfunction, etc); IIA, non-RCT based on colorectal cancer survivors; IIB, non-RCT based on cancer survivors across multiple sites; IIC, non-RCT based not on cancer survivors but on the general population experiencing a specific long-term or late effect (eg, chronic diarrhea, sexual dysfunction, etc); III, case study; and 0, expert opinion, observation, clinical practice, literature review, or pilot study.
some important aspects regarding the cardiovascular sys-tem in CRC survivors that should be noted. It has long been recognized that 5-FU can induce acute endothelial dysfunction, generally manifested as chest pain but rarely resulting in an acute myocardial infarction44,45 Therapy with capecitabine, a metabolite of 5-FU, has also rarely resulted in acute myocardial infarction.46 Individuals with preexisting coronary artery disease are at increased risk for this acute toxicity.44-46 Fortunately, once therapy is complete, there does not appear to be any lasting cardiovascular risk attributable to these 2
antimetabolite agents. To date, there has not been con-vincing evidence, beyond occasional case reports, of acute or long-term cardiotoxicity associated with oxali-platin therapy.
Although adjuvant therapy for CRC appears to have a relatively low risk for acute or chronic cardiotoxicity, there are indirect pathways within a subset of CRC survivors that may hasten the progression of cardiovascular disease (CVD). Obesity and sedentary lifestyles are associated with an increased risk of CRC.47,48Thus, it should not be surprising that, in a large, population-based cohort study,
TABLE 4. Summary of Potential Long-Term and Late Effects of Colorectal Cancer and Its Treatment
LONG-TERM EFFECTS LATE EFFECTS
Surgery
lOstomy care and complications lIncreased risk of bowel obstruction
lUrogenital/sexual dysfunction—eg, erectile dysfunction, dyspareunia, vaginal dryness, incontinence
lFrequent and/or urgent bowel movements or loose bowels
lGas and/or bloating
lIncisional hernia
Pelvic radiation
lUrogenital dysfunction/sexual dysfunction—eg, erectile dysfunction,
dyspareunia, vaginal dryness, incontinence
lInfertility
lGas lBowel obstruction
lChronic diarrhea lBone fracture in sacral region
lRectal ulceration and/or bleeding lSecond primary cancers in the radiation field
lRectal emptying problems/incontinence
lFrequent bowel movements
lAbdominal pain
lLocalized skin changes
Chemotherapy
lPeripheral chronic neuropathy lDental/oral complications
lCognitive function deficits—eg, confusion, lethargy
lChronic fatigue
General psychosocial (long-term and late effects)
lDepression
lDistress—multifactorial, unpleasant experience of psychological, social, and/or spiritual nature
lWorry, anxiety
lFear of recurrence
lFear of pain
lEnd–of-life concerns: Death and dying
lChanges in sexual function and/or desire
lChallenges with body image (secondary to surgery, hormonal therapy)
lChallenges with self-image
lRelationship and other social role difficulties
Hawkes and colleagues found that CVD was diagnosed by 36 months after the cancer diagnosis in 16% of survi-vors without known preexisting disease. The primary risk factors for developing hypertension, diabetes, and ische-mic heart disease were obesity at the time of CRC diagnosis and persistent sedentary lifestyles.49In a recent study, Cramer et al reported that CRC survivors, regard-less of whether or not they were treated with adjuvant therapy, had substantially reduced exercise capacity.50 This theme of diminished exercise capacity and cardiores-piratory fitness is common across cancer groups and is a key catalyst, when combined with preexisting obesity and lifelong sedentary behaviors, in the development of CVD.51Thus, it is imperative that primary care clinicians counsel CRC survivors regarding the well-studied adverse impact of obesity and sedentary behaviors and the critical need for modifications in what often have been lifelong habits.
Cognitive Function
Recommendation 10: (a) Screen for cognitive problems, (b) assess for depression and anxiety that may worsen cognition, and (c) refer for treatment. Level of evidence50
Patients have reported changes in cognitive function attrib-uted to cancer treatment with chemotherapy although the mechanism is still not well understood.52 The majority of studies focus on breast cancer patients, so there is a paucity of data on other cancers; however, a national cross-sectional study looked at self-reported memory problems and found that patients who had undergone treatment for cancer were 40% more likely to report memory problems than those without cancer, regardless of the type of cancer or treatment.53 In a prospective, population-based cohort of CRC survivors, chemotherapy was associated with wor-sening cognitive function, particularly for individuals younger than 70 years.54
The symptoms reported by patients who complain of cognitive decline vary but may include decreased executive functioning skills, slower processing time or reaction response, diminished organizational skills, loss of language or math skills, and/or difficulty with concentration or attention. These often translate into lower health-related QoL scores, especially as patients transition back to work.55 These symptoms can be difficult to interpret clinically, because there is often discordance between the subjective complaints of memory loss and objective testing. Memory impairment may be confounded by physical symptoms associated with treatment, such as fatigue or pain, as well as mental health concerns (stress, anxiety, or depression). The NCCN Guidelines for Survivorship9suggest screening for treatable causes that may worsen cognitive impairment, such as depression and anxiety, although data are lacking
for evidence-based recommendations regarding routine screening for cognitive decline in this population.
For patients who report a change in memory or cognitive function, there are a few tools, including the Mini Mental State Exam (MMSE) or the Functional Assessment of Can-cer Therapy Cognitive (FACT-Cog), which may be used for screening. A caveat of these screening tools is that they are not sensitive for determining deficits in executive function-ing, so they may underestimate cognitive decline.55For posi-tive screens, the next step would be a referral for formal neurocognitive testing. Neurocognitive testing can quantify and define specific problems that may impact activities of daily living or work, which can be helpful for patients to understand.
Unfortunately, there are no proven treatments for cogni-tive impairment related to cancer treatment; however, referral for cognitive rehabilitation strategies, eg, those used for patients after strokes, may be helpful, and studies testing the effects of physical activity on cognition are ongoing.
Dental/Oral
Recommendation 11: (a) Ask CRC survivors if they are experiencing symptoms of mucositis, loss of taste, or dry mouth and (b) treat similar to population with average risk. Level of evidence 50
In a prospective cohort study of CRC survivors, loss of taste and dry mouth were identified as significant late effects in patients who had received chemotherapy as measured by QoL scores 5 years posttreatment.54Dry mouth can lead to tooth decay, mouth sores, or gum disease. Empirical support for recommendations is lacking, although good oral hygiene (brushing teeth with fluoride-containing toothpaste, flossing regularly, etc) can prevent these complications. However, if the symptoms are severe, then referral to a dentist is recom-mended for further evaluation and management.
Distress/Depression/Anxiety
Recommendation 12: (a) Screen CRC survivors for psychosocial distress, depression, and anxiety using a validated screening tool; special attention should be paid to survivors with a stoma and those who report sexual dysfunction. Level of evidence5 I/0
(psychosocial screen), IIA (stoma)
(b) Refer patients to the appropriate mental health professionals or resources in the community as indicated; in addition, follow-up with the survivor to assess adherence and ensure that the need was met, identify potential barriers, and seek alternative approaches as needed. Level of evidence5 I
Where appropriate, these guidelines leverage the ASCO guideline adaptation of a Pan-Canadian Practice Guideline on Screening, Assessment, and Care of Psychosocial Distress (Depression, Anxiety) in Adults With Cancer.11